
FREQUENTLY ASKED
QUESTIONS ABOUT
GILENYA®
Not an actual patient.
We're here to help you with any questions you might have about GILENYA or the generic versions of GILENYA. If you have any additional questions about GILENYA or what the generics may mean for you, reach out to your health care professional, insurance company, or pharmacy for more information.
GILENYA & generic fingolimod
Is GILENYA now available as a generic?
Yes, the GILENYA brand of fingolimod has reached the end of its patent exclusivity period. This means that generic fingolimod options are now available for the treatment of RMS.
Now is a great time to talk with your doctor about how you are doing and how your current treatment is effectively managing your RMS.
In addition to GILENYA, Novartis is proud to offer another treatment option for adults with RMS.
This option includes:
- Proven safety and effectiveness
- Quick onboarding and support to help you get started
- Services you've come to expect
I'm taking branded GILENYA. What does it mean for me now that generics are available?
Now that generic fingolimod is available, this could mean:
- Your insurance company or pharmacy may switch you to a generic
- The medication you receive may look different from branded GILENYA or come in different packaging
- Generic fingolimod is not made by Novartis and won't come with the assistance and support from Novartis that you may currently receive
- Your out-of-pocket costs may be affected, and financial support from the branded GILENYA Prescription Co-pay Support Program will no longer be available to you
What is the difference between branded GILENYA and generic fingolimod?
The FDA approval for generic fingolimod, the active ingredient in GILENYA, is based on comparability to GILENYA in quality and efficacy.
What does the introduction of generic fingolimod mean for my child?
Like branded GILENYA, generic fingolimod is also approved for treatment of children 10 to 17 years of age. If your child is taking GILENYA, please contact your health care professional to find out how this change may impact your child's treatment and what treatment option is most safe and effective for them.
What branded GILENYA Go Program® services are available to me?
GILENYA Go Program services available for patients prescribed GILENYA prior to December 31, 2022 include*:
- GILENYA onboarding (pretest, first-dose observation [FDO])
- Co-pay financial assistance (for patients with commercial insurance). Patients will need to achieve their deductible based on their commercial insurance program requirements
As of January 1, 2023, no new patient Start Forms will be accepted for the GILENYA Go Program. For co-pay assistance, contact 1-855-443-1759.*
*For eligible patients with commercial insurance who do not reside in Massachusetts or California.
Will co-pay assistance be available for me if I start branded GILENYA after December 31, 2022?
Yes, co-pay financial assistance will be available (for patients with commercial insurance) through the end of 2023.* Patients will need to achieve their deductible based on their commercial insurance program requirements. To access the program, patients and health care professionals can call the co-pay support line for GILENYA at 1-855-443-1759.
*For eligible patients with commercial insurance who do not reside in Massachusetts or California.
Taking GILENYA
What if I'm noticing changes while on GILENYA?
If you are noticing any changes while on GILENYA, it may be time to talk to your doctor. Novartis offers another treatment option that may work for you. Explore another treatment option.
Is there another Novartis treatment for RMS?
Novartis offers a portfolio of RMS treatments to provide people with the best possible care. Treatment options are available for adults with RMS. Wherever you are in your MS journey, talk to your doctor about the other RMS treatment options available. Explore one of our treatment options.
Should I keep GILENYA in the refrigerator?
Nope! No need—simply keep GILENYA in a dry, room-temperature (68 °F to 77 °F) place that's out of reach of children.
I'm going to be traveling, how should I pack my GILENYA?
First off, make sure you have enough to get you through your time away and call in a refill if you're short. If you're traveling by plane, keep GILENYA in your carry-on so it doesn't get lost along the way. For car journeys, just make sure GILENYA is kept in a spot that won't get too hot.
What if I forget to take a dose?
Call your health care professional for advice if you miss a dose, or if you're thinking about stopping treatment with GILENYA—it's important that you don't stop without talking to them first.
Starting GILENYA
I am ready to start GILENYA. How do I get started?
Tell your health care professional why you're interested in GILENYA and ask them all your questions. Need help getting that conversation started? Learn more about starting GILENYA. If you have any additional questions, speak with your health care professional.
What's a first-dose observation (FDO)?
An FDO is monitoring done during your first day on GILENYA. Your health care professional can explain more about why it's done and what to expect. It typically takes about 6 hours, and you can do stuff like read, work, or watch movies while the time passes. Learn more about starting GILENYA.
Where will my FDO happen?
At your health care professional's office or at another medical facility—you and your health care professional will decide where's best for you.
What's a specialty pharmacy?
Prescriptions for GILENYA are filled by specialty pharmacies. These pharmacies have a few perks:
- They support you in ways like answering your questions, making sure you always have enough GILENYA, and finding ways to help you save
- They deliver GILENYA right to your door, so you can skip those long lines at the local pharmacy
- They work closely with your health care professional to help them manage your treatment plan
What should I know about GILENYA and family planning?
GILENYA may harm your unborn baby. Effective birth control should be used by people who may become pregnant while taking GILENYA and for at least 2 months after stopping. If you become pregnant or are thinking about trying to become pregnant, tell your health care professional right away.
A pregnancy registry is available for those who become pregnant during GILENYA treatment. Learn more by visiting www.gilenyapregnancyregistry.com.
I'm a new mom on GILENYA—anything I should know?
It's not known if GILENYA passes through breast milk, so ask your health care professional about the best way to feed your baby.
GILENYA & COVID-19
Can I get the COVID-19 vaccine or vaccine boosters before starting GILENYA?
It's understandable to have questions about getting a COVID-19 vaccine or vaccine booster. Vaccines, like the COVID-19 vaccines and vaccine boosters, are an important part of public health. So, you should talk to your doctor to better understand the types of vaccines and vaccine boosters available to you and how to manage getting a vaccine or vaccine booster before starting GILENYA.
The GILENYA Medication Guide does not advise against taking non-live vaccines or boosters; however, they may not work as well when given during treatment with GILENYA.
The National Multiple Sclerosis Society (NMSS) offers more information and guidance on COVID-19 and RMS. Visit their website at nationalmssociety.org.
For more information about COVID-19, visit the Centers for Disease Control and Prevention (CDC) website at CDC.gov and search: COVID-19 vaccines or COVID-19 vaccine boosters.
Can I get the COVID-19 vaccine and vaccine boosters while taking GILENYA?
It's understandable to have questions about getting a COVID-19 vaccine or vaccine booster. Vaccines, like the COVID-19 vaccines and vaccine boosters, are an important part of public health. So, you should talk to your doctor to better understand the types of vaccines and vaccine boosters available to you and how to manage getting a vaccine or vaccine booster while taking GILENYA.
The GILENYA Medication Guide does not advise against taking non-live vaccines or boosters; however, they may not work as well when given during treatment with GILENYA.
The National Multiple Sclerosis Society (NMSS) offers more information and guidance on COVID-19 and RMS. Visit their website at nationalmssociety.org.
For more information about COVID-19, visit the Centers for Disease Control and Prevention (CDC) website at CDC.gov and search: COVID-19 vaccines or COVID-19 vaccine boosters.
Are the available COVID-19 vaccines live or non-live?
Just like some other vaccines you may have received in the past, the COVID-19 vaccines available in the United States as of September 2022 are non-live vaccines. That means the vaccines do not contain live virus and will not cause COVID-19 disease.
Are there any known risks of getting the COVID-19 vaccine while being treated with GILENYA?
The GILENYA Medication Guide does not advise against taking non-live vaccines; however, they may not work as well when given during treatment with GILENYA. COVID-19 vaccines haven't been specifically studied in people taking GILENYA. When we have more clinical information, we'll reach out to both you and the health care community.
As always, your doctor will be the best person to talk to about your overall health concerns and to help make decisions about your treatment.
Where can I get more information about COVID-19 and vaccines for people with RMS?
The National Multiple Sclerosis Society (NMSS) offers information and guidance on COVID-19 for people living with RMS. Your doctor is also a trusted source for guidance on this topic.

Still have questions?
We're ready to answer them at 1-888-NOW-NOVA (1-888-669-6682), 8:30 AM to 5:00 PM ET, Mon-Fri.*
MS=multiple sclerosis; RMS=relapsing MS.
GO PROGRAM is a registered trademark of Novartis AG.
*Excludes public holidays.